Overview
- 14 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-10-24.
At a glance
Inspections
14
Form 483s
6
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 21 Oct 2024 – 24 Oct 2024 | Human Drugs | Clean | |
| 24 Jun 2024 – 28 Jun 2024 | Human Drugs | 483 | View 483 → |
| 6 Mar 2023 – 10 Mar 2023 | Human Drugs | 483 | View 483 → |
| 14 May 2018 – 18 May 2018 | Human Drugs | 483 | On file |
| 30 Oct 2017 – 3 Nov 2017 | Human Drugs | Clean | |
| 13 Feb 2017 – 17 Feb 2017 | Human Drugs | 483 | On file |
| 22 Feb 2016 – 26 Feb 2016 | Human Drugs | Clean | |
| 1 Dec 2014 – 5 Dec 2014 | Human Drugs | 483 | On file |
| 23 Sep 2013 – 27 Sep 2013 | Human Drugs | Clean | |
| 25 Feb 2013 – 1 Mar 2013 | Medical Devices & Rad Health | Clean | |
| 29 Apr 2011 | Not recorded | Clean | |
| 27 Jan 2011 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
28 Jun 2024
21 CFR 211.160(b)(4)
Establishment of calibration procedures
Cited by David A Oluwo, Kenneth H Williams
28 Jun 2024
21 CFR 211.192
Investigations of discrepancies, failures
Cited by David A Oluwo, Kenneth H Williams
28 Jun 2024
21 CFR 211.194(d)
Laboratory equipment calibration records
Cited by David A Oluwo, Kenneth H Williams
28 Jun 2024
21 CFR 211.63
Equipment Design, Size and Location
Cited by David A Oluwo, Kenneth H Williams
Investigators
FDA investigators tied to this site in the record.
MRA M BarbosaR1 insp.
David A Oluwo1 insp.
Kenneth H Williams1 insp.
Teresa I Navas1 insp.
Miguel A Martinez1 insp.
Yvesna C Blaise1 insp.
Parul M Patel1 insp.
Laura Fontan1 insp.
Deyaa Shaheen1 insp.
Paul L Bellamy1 insp.
Jose A Lopez Rubet1 insp.
Ramon A Hernandez1 insp.
Yumi J Hiramine1 insp.
Lauren E Skokan Priest1 insp.
Deborah A Greco1 insp.
Minh D Phan1 insp.
Mark E Parmon1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.194(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.48(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind HOVIONE FARMACIENCIA, S.A.'s 6 Form 483s
Source PDFs and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat